Z-1315-2014Class II

Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a...

Name: Z-1315-2014 Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a...
Creator: Roche Diagnostics Operations, Inc.
Published: 2014-02-28
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2014-02-28 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001... on 2014-02-28. FDA classified it as Class II and gives the reason as "Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1315-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-28
Posted: 2014-04-02
Terminated: 2018-01-10
Recalling firm: Roche Diagnostics GmbH
Product: Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b 221<4>Roche OMNI S4 system Product Usage: Usage: Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin
Reason for recall: Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected.
Root cause tag: design
FDA root cause: Device Design
Action: Roche Diagnostics Operations sent an Urgent Medical Device Correction letter dated February 27, 2014 via UPS Ground (receipt required) to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed fax form and fax it to 1-888-345-0253. For questions contact Roche Customer Business Support Center at 1-800-428-5076.
Distribution: Worldwide Distribution - USA nationwide including PR and the country of Guam.
Product codes and lots: all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1315-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1315-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-01

K032311Class IIRoche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. / cleared 2003-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)